New options for medicine and medical equipment industry

Marketing supervisor general・Quality assurance manager・Safety supervisor

A consulting firm that supports all 3 tasks

image

Consulting Service

image

Post-Marketing Pharmaceutical Service

image

Safety Management Service

OUR BUSINESS

Support resolving company’s problems
with broad services

Offering various services
mainly from consulting.
By using our strength of getting three key roles done in one-stop,
we will guide to resolve problems.

images

Consulting

Construct work analysis and operational improvement for safety management operation efficiency

Advise and interview support for responding inquiry matters to authorities

Support obtaining and renewing the authorization of manufacturing and distribution

Prepare various SOP

Construct CTD2.7 and package insert draft

Others

images

Safety Management

Accept whole medicine and medical device’s safety management operation

Collect, analyze and measure safety management information (adverse event)

Safety evaluation using our own Safety database Arisglobal (after clinical trials and post marketing)

Construct forms such as RMP, PBRER, DSUR, unknown non-serious regular case report and infectious disease regular report

images

Post-Marketing Pharmaceutical

Construct package insert and related documents

Correspond inquiry matters from authorities

CMC pharmaceutical operation

Support certificate of approval

Support drug price calculation process

SERVICE

REASON
Why it is chosen

CUES Consulting INC. will support and carry out quality control・safety management operation which are essential for manufacturing and distributing the medicine and medical equipment.
We are also capable of assisting overall operations including marketing supervisor general tasks.

CUES
is chosen
Reason

1

Assisting entire
3 manufacturing roles

2

Highly
specialized staff

3

High cost
performance

4

Global standard
quality

FLOW
Operational flow

Operation term

A

From inquiry to estimation
⇒ about 1 week

B

• When consulting/ creating application form etc.
⇒ Earliest as 1 week~ after agreement

• When using data base
⇒ Earliest as 3 months ~

images 01

Inquiry

A

Contact us from the inquiry form by phone.

images 02

Reviewing

A

Person in charge will contact you and review your current situation and requests.

images 03

Proposal・Estimation

A

We will propose the estimation and the best plan from reviewing the customer’s needs.

images 04

Contract・Place an order

B

We will sign a contract necessary for placing the order such as non-disclosure agreement.

images 05

Offering services

B

We will operate the services discussed in the proposal.

images 06

Confirmation・Delivery

Please confirm the final products.
It will be delivered after any modification.

images 07

Payment

We will close at the end of delivered month and issue the invoice. Please pay by the end of the following month.

CORPORATE POLICY

Providing low-cost and the Global Head Office
standard quality

CUES Consulting INC. was founded to improve our client’s operation and from the spirit of “Constructing a structure that can provide proper resources and advanced knowledge.”

Medicine and medical equipment are increasingly demanded from the regulatory authority.
Whereas for a startup company or a company whose supplies are limited, are having difficulties trying to meet the compliance that’s been rising each year and with just small staff members covering broad tasks.
I have worked at the mega pharma to operate security management for many years. After this, I transferred to a smaller pharmaceutical company as a safety manager and struggled with a dilemma of not having enough resources and operation improvements progressing in a slow speed.
With these experiences, CUES Consulting INC. was founded with the attention to establish a structure that can provide proper resources and advanced knowledge even for smaller companies. With having organized mainly with experienced medicine’s marketing supervisor generals and safety supervisors, our mission is to provide services with a reasonable price from clinical trials to marketing, overall support of three key roles including generalization and improving compliance and operation for small medicine・medical equipment companies.
Furthermore, our specialties are to suggest proposals for efficient management operations, negotiate with authorities and Global Head office and pharmaceutical works from our experiences.

CUES Consulting INC. will continue to seek for limitless possibilities.

Representative Director
Motoyuki Takano

images

COMPANY PROFILE

Aiming to become the best partner for medicine and medical equipment manufacturer

With high expertise, the experienced Marketing supervisor general
・Safety supervisor staff will answer all the diverse requests and reduce customer’s operation.

Company Name CUES Consulting INC.
Representative Motoyuki TAKANO
Employees 10
Address 9-3 Nibancho, Chiyodaku, Tokyo
102-0084
Tel 03-6803-6361
URL https://cues.or.jp/
Our Services

1.Consulting Service

Construct work analysis and operational improvement for safety management operation efficiency

Advise and interview support for responding inquiry matters to authorities

Support obtaining and renewing the authorization of manufacturing and distribution

Prepare various SOP

Construct CTD2.7 and package insert draft

Others

2.Safety Management Service

Accept whole medicine and medical device’s safety management operation

Collect, analyze and measure safety management information (adverse event)

Safety evaluation using our own Safety database Arisglobal (after clinical trials and post marketing)

Construct forms such as RMP, PBRER, DSUR, unknown non-serious regular case report and infectious disease regular report

3.Post-Marketing Pharmaceutical Service

Construct package insert and related documents

Correspond inquiry matters from authorities

CMC pharmaceutical operation

Support certificate of approval

Support drug price calculation process

Clients Major foreign affiliated medicine manufacture, Major domestic medicine manufacture, Medical equipment manufacture
Main Bank Tokyo Mitsubishi UFJ, Sumitomo Mitsui, Mizuho
Access By train transportation: 1 minute walk from Tokyo Metro Yurakcho Line “Kojimachi Station”
PRIVACY POLICY